FDA Grants Approval of Taletrectinib for ROS1-Positive NSCLC

Today, the FDA has granted approval to taletrectinib (Ibtrozi, Nuvation Bio Inc), a kinase inhibitor, for the treatment of locally advanced or metastatic ROS1-positive non–small cell lung cancer (NSCLC) in adults, according to an announcement.

The organization previously granted priority review, breakthrough designation, and orphan drug designation to the application for the drug.

The FDA announcement highlighted that two multicenter, single-arm, open-label clinical trials, TRUST-I and TRUST-II, evaluated efficacy of the drug in 157 patients who were naïve to treatment with a ROS1 tyrosine kinase inhibitor (TKI) and 113 patients who had received one prior ROS1 TKI. Officials also noted that patients “may have received prior chemotherapy for advanced disease.”

Overall response rate (ORR) and duration of response (DOR) were determined as “major efficacy outcome measures” through a blinded independent central review. In TRUST-I, ORR was 90% for treatment-naïve patients and 85% in TRUST-II. A DOR of 12 months or longer was demonstrated among responders in both trials, measuring at 72% and 63%, respectively.

Furthermore, the announcement outlined that ORR was 52% for TKI-pretreated patients in TRUST-I (95% CI, 39%-64%) and 62% in TRUST-II (95% CI, 46%-75%). A DOR of 6 months or longer was demonstrated in 74% of responders in TRUST-I and in 83% of responders in TRUST-II.

FDA officials emphasized that prescribers should be aware of the medication’s warnings and precautions, which include hepatoxicity, interstitial lung disease and pneumonitis, QTc interval prolongation, hyperuricemia, myalgia with creatine phosphokinase elevation, skeletal fractures, and embryo-fetal toxicity.

“The recommended taletrectinib dose is 600 mg orally once daily on an empty stomach (no food intake at least 2 hours before and 2 hours after taking taletrectinib) until disease progression or unacceptable toxicity,” officials explained in the announcement.